Soft Bitewing Flaps

Basic Information

• Brand Name: Soft Bitewing Flaps
• Primary DI: D2486563031
• Version / Model: 656303
• Company Name: HAGER WORLDWIDE, INC.
• Labeler DUNS: 009277971
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2023-07-13
• Public Version: 1
• Public Version Date: 2023-07-21
• Public Version Status: New
• Public Device Record Key: ae8b52df-b7d4-4107-9131-ec76e78af9cb

Device Description

Foam flaps to hold bitewing x-ray films

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EGZ	Holder, film, x-ray	Dental	872.1905	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65130	Dental x-ray film holder, single-use	A device designed to stabilize a dental x-ray film intraorally during the taking of a dental x-ray. It is typically an adhesive-backed device designed to fold into a T-shape which adheres to the x-ray film and provides a tab that, when bitten down on, stabilizes the film adjacent to the teeth whilst the x-ray is being taken. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D2486563030	HIBCC
Primary	D2486563031	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]